• 
  ISO 9001

  The ability to consistently provide products and services that meet customer and regulatory requirements

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  ISO 13485

  Medical equipment and quality management systems that always meet customer and regulatory requirements

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  MDR

  The new European Medical Device RegulationUnder processing now

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  FDA

  U.S. - The Food and Drug Administration. FDA 510(k) cleared

The ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements